NIH, National Heart, Lung, & Blood Institute, BDR Contracts Section, Contracts Operations Branch, Rockledge Building (RKL2), Room 6135, 6701 ROCKLEDGE DR MSC 7902, BETHESDA MD 20892-7902

A -- REFINEMENT OF NEW ASSAYS FOR DIRECT DETECTION OF VIRAL NUCLEIC AC IDS IN DONATED ORGANS SOL NHLBI-HB-95-09 POC Lynda A. Bindseil, Contracting Officer, (301) 435-0355. The major objectives of this program are: 1) to refine for use in clinical laboratories, one or more nucleic-acid based techniques that will be feasible for the direct detection of blood-borne viruses in donors of organs for transplantation to reduce the antibody-negative window period between infectivity and detection to the shortest possible time and, when possible, obviate the need for indirect antibody tests, and 2) to file for investigational new drug exemptions (INDs) with the Food and Drug Administration (FDA), and submit and obtain approval for product license applications (PLAs). Presently available information indicates that the first detectable evidence for infection with HIV is a burst of RNA virus in circulating plasma about 7-10 days after the infecting episode. Hence, this solicitation requires a test to detect this RNA virus burst. Nevertheless, in the replicative cycle of HIV, infectious RNA virus is first transcribed into DNA provirus which in turn is followed by an RNA viremia. A test to detect the provirus might be positive earlier than one that detects the RNA burst. Such a DNA test would be acceptable, provided sufficient data are included to support its value in shortening the window period to the maximum extent possible (equivalent to or shorter than a test for HIV RNA). In addition, because of its clinical importance, HCV must also be detected in a similar system. To improve practicability, the detection of more than one agent per test (multiplex system) is an important goal. The two highest priority viruses to be detected, HIV and HCV, may or may not lend themselves to multiplexing together. The testing method(s) envisioned must be able to detect each of these viruses, alone or in multiplexing format, but earlier availability of an individual test is more important than a later availability of multiplexed tests. The preclinical phase (Phase I) for an organ donor assay shall be completed within 12 months from contract award. The contractor shall refine a procedure for screening of neomot organ donors for blood-borne viruses. The contractor must demonstrate that the organ donor assay detects minimal amounts of viral nucleic acids (RNA and/or other viral nucleic acids that appear at the same time or before the earliest appearance of viral RNA circulating in plasma) specific for HIV and HCV. Tests for other blood-borne viruses (e.g., HTLV-I or II) are beyond the scope of this project, but may legitimately be part of multiplexing plans for the future. The clinical phase/test validation shall be conducted at approved clinical trial sites and must be completed and the results submitted to the Center for Biologics Evaluation and Research (CBER) within a period of 20 months from receipt of the IND. An additional 4 months will allow for review of data by CBER officials and, ultimately, licensure of the procedure. It is anticipated that one (1) award will be made from this solicitation and that the award will be made on or about June 1, 1996. It is anticipated that the award will be a multiple-year cost reimbursement completion contract with a term of three (3) years. RFP NHLBI-95-09 will be released on or about September 22, 1995. To expedite requests for solicitation, please furnish three (3) self-addressed labels with your request. (0249)

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